Performance Study to Test the GlucoMen®Day System Using Intravascular and Subcutaneous Microdialysis in Subjects With Type 1 Diabetes
Over the last years, a number of systems for continuous subcutaneous glucose monitoring have been marketed and are routinely used in patients with diabetes to obtain more detailed information about 24-hour glucose profiles.
In the hospital, numerous factors influencing glycemic control and possibly leading to glucose excursions out of the desired range exist, e.g. interventions for which the patient has to remain fasting or medications such as corticosteroids or vasopressors. A reliable continuous glucose signal could help to observe levels of glycaemia not only at defined time-points but continuously, making it possible for physicians and nursing staff to better adjust antihyperglycemic therapy and to react before the patient is exposed to severe hypo- or hyperglycaemia.
In the hospital setting, vascular access is granted in the majority of patients and could as well be used as an alternative site for continuous glucose monitoring.
The aim of the present study is to assess accuracy of the glucose data obtained by means of an intravascular microdialysis-based CGM system against venous blood glucose reference measurements.
|Type 1 Diabetes||Device: Vascular microdialysis using the GMD-system Device: Vascular and subcutaneous microdialysis using the GMD-system|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Single-center, Open, Pilot Trial to Investigate the Performance of the GlucoMen®Day System Using Intravascular and Subcutaneous Microdialysis in Subjects With Type 1 Diabetes|
- Point Accuracy of the microdialysis signal [ Time Frame: 72 hours ]MARD (mean absolute relative difference), MARE (mean absolute relative error), %Press analysis
- Rate accuracy of the microdialysis signal [ Time Frame: 72 hours ]R-EGA (rate error grid analysis) and P-EGA (point error grid analysis)
|Study Start Date:||November 2012|
|Study Completion Date:||April 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Type 1 Diabetes - vMD and sMD
Patients will undergo vascular (vMD) and subcutaneous microdialysis (sMD) using the GMD-system (GlucoMen(R)Day-system)
Device: Vascular and subcutaneous microdialysis using the GMD-system
Glucose levels will be monitored by means of vascular and subcutaneous microdialysis using the GlucoMen(R)Day system
Type 1 diabetes - vMD
Patients will undergo vascular microdialysis (vMD) using the GMD-system (GlucoMen(R)Day-system)
Device: Vascular microdialysis using the GMD-system
Glucose levels will be monitored by means of vascular microdialysis using the GlucoMen(R)Day system
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709851
|Medical University of Graz, Dept. of Internal Medicine, Endocrinology and Metabolism|
|Graz, Austria, 8036|
|Principal Investigator:||Thomas R. Pieber, MD||Medical University of Graz|